Cidara submits new drug application for and licenses antifungal

After promising results from separate Phase 2 and 3 trials, Cidara Therapeutics has submitted a new drug application to the US Food and Drug Administration (FDA) for the compound rezafungin, for which the company expects a response in early 2023 if the FDA accepts the drug candidate for review. Designated as an orphan drug, the molecule aims to treat and prevent yeast infections in the bloodstream and among people undergoing blood or marrow transplantation. In a deal potentially worth $460 million, Cidara has also agreed to license rezafungin exclusively to Melinta Therapeutics for commercialization in the US.